Nova Max Blood Glucose Monitor Owner’s Guide

1 nova Biomedical200 Prospect StreetWaltham, MA 02454-9141 Telephone: 1-800-681-7390 Web site: in the USA by nova Biomedical Patent No. 6,258,229, 6,837,976, 6,942,770, CA 2,375,089 and other and foreign patents Max is a registered trademark of nova 2007 nova Biomedical Corporation 40677 Rev E 05/2009 nova Max Blood Glucose Monitor owner s GuideNova thanks you for choosing the nova Max Blood Glucose Monitor . This owner s Guide contains important information on the Monitor and how it works. Please read it carefully before us-ing your new nova Max Blood Glucose Monitor is designed to be conve-nient and easy to use. It gives accurate results in just 5 seconds using a very small Blood sample. This small sample allows you to use a thinner lancet because not as much Blood is needed to do a Blood sugar test. The Monitor also has memory that stores your Blood sugar test results to help you and your healthcare profes-sional manage your diabetes you get started, it is important to complete the Warranty Registration Card included in your kit and mail it back to nova .

2 Doing this will help us better serve your you need to contact us, please call Customer Service 24 hours a day, 7 days a week, in the US at 1-800-681-7390 or visit our web-site at YOU Before you begin using your new Blood Glucose Monitor , please read all of the instructions provided in this owner s Guide . Your Monitor uses a CR2450 3-volt coin cell battery. To begin using your Monitor , you need to install the enclosed battery. See Battery Replacement (page 29) to install a new battery. Perform all quality control checks recommended in your owner s Guide . Consult with your diabetes healthcare professional and follow his/her guidance for your Blood Glucose monitoring routine. These recommendations apply to all Blood Glucose monitors and are supported by the American Association of Diabetes Educators (AADE), the American Diabetes Association (ADA), the US Food and Drug Administration (FDA), and the Advanced Medical Technology Association (AdvMed).

3 Notes, Cautions, and Warnings:NOTES provide helpful operating provide information that is important for instrument provide information that is important for user protec-tion or about risk for inaccurate Information!Table of ContentsIntended Use ..1 Symbols ..2 Introduction ..3 Monitor Components ..3 Monitor Display ..4 The nova Max Blood Glucose Monitor ..5 Overview ..5 Kit Contents ..6 Environmental ..6 Before Testing ..7 Reasons to Check for Low Blood Glucose ..7 Important Health Related Information ..7 Test Strips ..8 Important nova Max Test Strip Information ..8 Lancing Device ..9 Setting the Time, Date, and Beeper .. 10 Control Solution .. 12 Perform a Control Solution Test .. 12 Important Information for Control Solution .. 13 Testing a Quality Control Solution .. 14 Running a Test .. 17 Getting and Applying a Blood Sample from Forearm or Palm .. 20 Limitations and Considerations: Forearm and Palm Testing.

4 22 Your Test Result .. 24 Review Test Results in Memory .. 26 TOC-1 Basic Upkeep .. 28 Battery Check .. 28 Battery Replacement .. 29 Cleaning and Care .. 30 Displays, Meanings, Actions .. 31 Appendix .. 37 Specifications .. 37 Chemistry Measurement .. 37 Limitations .. 38 Instructional Notes .. 40 Warranty .. 42 TOC-21 The nova Max Blood Glucose Monitor is intended to be used for the quantitative measurement of Glucose in capillary whole Blood . It is intended for use by people with diabetes mellitus in the home as an aid to Monitor the effectiveness of diabetes con-trol. The nova Max Blood Glucose Monitor is specifically indicat-ed for the quantitative measurement of Glucose in whole Blood capillary samples obtained from the fingertip, palm and forearm. The nova Max Blood Glucose Monitor is intended for use outside the body (in vitro diagnostic use). It should only be used with nova Max Test Strips and nova Max Control Solution.

5 It should be used for testing Glucose (sugar) and only with fresh capillary whole Blood samples. It should NOT be used to diagnose diabetes or to test new-borns. It should NOT be stored in the refrigerator or in the : The nova Max Blood Glucose Monitor contains small parts. Keep the Monitor out of reach of small children and you have hypoglycemia unawareness, a Blood Glucose moni-tor is critical to your care. Since any Monitor may fail, break, or be misplaced, you should always have a backup Use2 WARNING: Blood samples and Blood products are po-tential sources of hepatitis and other infectious agents. Handle all Blood products with care. Wear gloves when performing measurements on another person. Items that are used to measure Glucose , , test strips, lancets, and alcohol swabs, must be disposed of in accordance to local regulations to avoid risk to following are symbols that are used in this manual, on insert sheets, and on the nova Max Blood Glucose Monitor .

6 In vitro diagnostic medical device Caution, consult accompanying documents Consult instructions for use Biological risk Catalog number Temperature limitationSymbols3 nova Max Blood Glucose MonitorLCD DisplayLeft Arrow ButtonMode ButtonRight Arrow ButtonTest Strip Goes HereIntroductionMonitor Components4 Marked Test ResultsMemory ResultBlood or Control Drop IndicatorControlLow Battery IndicatorGlucose Test Results mg/dLAverage Test ResultsAM or PM IndicatorDate/DayNova Max Monitor ScreenIntroductionMonitor DisplayWhen you turn the nova Max Blood Glucose Monitor on, the all segments display appears briefly. This tells you that all the dis-play segments are working nova Max Blood Glucose MonitorThe Monitor is a hand-held testing device that measures Glucose (sugar) in capillary Blood . The test strip is touched to a drop of Blood to initiate the test process. A simple one-step process provides a Blood Glucose result.

7 Test results are available in 5 seconds. There is memory for one common user s set of test results (400). The Monitor is powered by a battery that can perform for ap-proximately 1000 tests. CAUTION: The Monitor should be handled with care. Dropping, rough handling, etc. may damage the Monitor . If the Monitor is not to be used for an extended period of time, remove the battery to eliminate the risk of battery leakage. Also, protect the Monitor from moisture, prolonged direct sunlight, and extreme perform a test, the operator simply inserts a test strip; waits for the Blood drop symbol to appear on the screen; brings the test strip to the drop of Blood ; and obtains a Glucose test result in 5 seconds. The test result is automatically stored into the moni-tor s memory. The operator can recall and review test data stored in the Monitor , including the average for user Contents1. nova Max Blood Glucose Monitor2.

8 Vial of nova Max Glucose Test Strips (10)*3. Lancing device*4. Lancets (10)*5. nova Max Blood Glucose Control Solution, Normal (1 bottle)*6. Battery (CR2450, 3V)7. Quick reference guide8. owner s Guide 9. Log Book10. Warranty Card11. Getting Started Poster* These items are not included in the mail order ver-sion of the The storage temperature range for the Monitor : -13 F to 115 F (-25 C to 46 C) The storage temperature range for the Test Strips: 59 F to 86 F (15 C to 30 C) The Monitor operational temperature range: 57 F to 104 F (14 C to 40 C) The relative humidity range: 10% to 90% non-condensingIntroduction7 IntroductionBefore TestingBefore testing and to ensure accurate Glucose results, wash your hands and the testing site then thoroughly dry these areas. The nova Max Blood Glucose Monitor can test your Blood glu-cose on the fingers, forearm, or palm. The sample size is just L of to Check for Low Blood Glucose You have symptoms such as weakness, sweating, nervous-ness, headache, or confusion.

9 You took insulin, but have delayed eating. Your doctor or healthcare professional advises you to do Health Related InformationIf you are experiencing symptoms that are not consistent with your Blood Glucose test results and you have followed all instruc-tions described in the owner s Guide , call your doctor or health-care StripsThe nova Max Test Strips are designed for use with your nova Max Blood Glucose Monitor only. Use each test strip only once, then discard. DO NOT reapply Blood to the test strip. Requires a very small Blood volume: L Automatically draws Blood into the test area of the strip Can be handled with clean, dry hands without affecting glu-cose readingsImportant nova Max Test Strip Information Use only nova Max Test Strips when testing. Remove the test strip from the vial only when ready to test. Store the test strip package in a cool, dry place below 86 F (30 C). Do not refrigerate or freeze.

10 Do not store near heat or moisture. Store the test strips in their original vial only. After removing a test strip from the vial, immediately replace the vial cap and close tightly. Do not use test strips beyond the expiration date printed on the package as this may cause inaccurate Blood Drop to Front EdgeInsert This End Into Monitor9 Test strips should only be stored for 3 months after opening the vial. When first opening a new vial of test strips, count forward 3 months and write that date on the vial. Discard any remaining test strips after the date you have written on the vial. Do not tamper with the test : The test strip vial contains small parts. Keep the test strip vial away from children and DeviceThe diagram below shows the components of the Lancing Device. Refer to the Instructions for Use insert sheet for the Lancing Device for detailed AdjustmentRelease ButtonForce Adjustment10 Setting the Time, Date, and BeeperSetting the Time, Date, and BeeperHaving the correct time and date of each Blood Glucose test result helps you and your healthcare professional track changes in your therapy.